[Musculoskeletal tissue banks. Legal foundations and graft safety]

The regulations in the recent German Tissue Act have completely changed the working situation for musculoskeletal tissue establishments. According to the requirements of section 20b, section 20c and section 21a AMG it should be possible to maintain local bone banks but centralised regional tissue banks will dominate in the future. The transmission of viral and non-viral infectious pathogens continues to be the most serious of the potential adverse effects of allogenic tissue transplants. Accordingly, tissue banks must focus on comprehensive and robust quality assurance in the areas of donation, testing, processing and preservation. Whenever possible, a validated inactivation procedure should be included in the manufacturing process of musculoskeletal tissue transplants.